Today’s announcement is the most significant since the positive CHMP decision 18 months ago. The difficulties with the EMA related to post marketing approval can now be forgotten and we can focus on the future. With the final sign off by the EMA only a few months ago, to get to this stage actually seems relatively quick (PBAC in Aus can take years following TGA approval). Netherlands is done, with Germany and Austria to follow next month. It appears that some insurance companies will pay in Switzerland (not bad considering it is not even formally approved by SwissMedic). NICE (UK) will decide within the next 3 months or so. We also know that Clinuvel are negotiating with other countries.
Clinuvel have always maintained, and reiterated today, that pricing will be consistent throughout Europe. Whilst any mention of price was omitted from todays announcement we know this from previously published sources at around 22,000 Euros per implant. Revenues will probably not be significant until the 4C in January 17, due to delays in receiving the actual cash. I don’t expect any formal financial guidance from Clinuvel so it is still 6 months or so of guessing revenues. Wolgen has provided vague guidance during AGM presentations in the past so this is a possibility, but that is still 5 months away.
Trading in Clinuvel was largely unaffected by this significant announcement. This would not have been a surprise to any who closely watch trading in this stock, but it is a bit frustrating all the same. I am now convinced that the share price will drift until revenues rise to the point that the stock cannot be ignored. A takeover by big pharma is considered a very remote possibility.
Other catalysts for share price appreciation are unlikely. The vitiligo program has essentially not progressed for 4 years. The final results of the Singapore fiasco may be released later this year, but the execution of the trial was so poor that I expect we will never hear of this trial again. An animal trial in the US was also due for completion by now. This was not expected to give any new information but was an FDA requirement prior to proceeding with a 2b. This 2b trial may be announced this year, but Clinuvel currently have no cash to complete a meaningful study in the US, so are probably not in a hurry.
FDA approval for EPP seems further off than ever. After the Type C meeting 9 months ago, the FDA was given the data package to consider whether an NDA was appropriate. It is unknown whether the FDA has looked at this, certainly they have not invited a dossier submission. The APF, courtesy of Desiree Lyon, have secured a meeting with the FDA in October to press their case, it therefore seems very unlikely that any news will be forthcoming prior to that time. I now expect the FDA will request a further EPP study. With a desperate and organised patient population and a safe effective drug we can be left to wonder why Clinuvel have not been more proactive in this space. They could have completed 2 or more properly designed P3 US trials since CUV039 completion. I still think FDA approval will happen but it will be several years away. Clinuvel dropped the ball on this one.
HHD has disappeared. A second physician sponsored trial was due to have been completed. Clinuvel and the investigators will not comment whether this has occurred. Clinuvel did obtain orphan designation with EMA and FDA and also submitted a patent application. I expect lack of news is Clinuvel strategy and this indication will be on the back burner until EU EPP revenue has stabilised.
Despite not becoming anywhere near as wealthy as imagined and being quite a lot older than anticipated today’s announcement makes me feel like I have backed a winner. It is rare indeed for an Aus biotech to go from preclinical to sale of an approved drug. This is rarer still with a NME (probably never) whilst providing distribution and marketing in house. Sure this journey has been painful and frustrating but maybe today is the first day of the new Clinuvel. The market cap of 200 million is ludicrous.
CUV Price at posting:
$4.25 Sentiment: Buy Disclosure: Held
(20min delay)